PSI ToxSIG Webinar: Combining Sexes
The webinar will provide a general introduction to the topic of combining sexes for statistical analysis in Toxicology. It will also discuss guideline recommendations pertaining to this topic.
James Bell (Elderbrook Solutions GmbH)
3 years as a trial statistician, 2 years as a methods statistician, 2 years in drug discovery
PhD in computational chemistry, followed by 2 years in computational drug discovery. Subsequently retrained with an MSc in medical statistics. Spent three years as a trial statistician with Boehringer Ingelheim, and then internally transferred into a statistical methods role. Moved to a CRO as a contract statistical methodologist providing technical support for statisticians at a major pharmaceutical company.
As I work with statisticians in Europe, Asia and the US, a typical day will start with triaging overnight emails; providing short written replies to the simpler technical-support questions, and arranging meetings to discuss their more complex statistical problems. These will mostly relate to the first strand of the role; ad-hoc support for trials and projects with statistical issues. These engagements may last for anything from one email or phone call up to a week or two of support and are often associated with regulatory interactions, or queries about how to specify or implement a method.
The rest of the morning may involve providing on-going support for a larger single issue faced by a particular trial or projects – these interactions typically relate to trial design and last for several months. They often require substantial amounts of literature searching, programming in R and/or novel research. Meetings with the statisticians involved in the trials and projects I am supporting are common, typically once or twice a day.
The afternoon might involve work on a policy initiative; researching, identifying and writing best practice documents in a particular area of statistics that can then be applied across multiple trials. This will typically also involve writing slides to summarise and present the initiative.
No two days are the same though, with a great variety of tasks. Days can be very busy, with many different requests and meetings all competing for time. They can also be very quiet, where you may just focus on one part of a larger task; occasionally you may spend a whole day programming, slide writing or researching.
The sheer variety is the best part. As mentioned above, there is no typical day, with the only common thread being the need to be constantly thinking and questioning. Aside from the different types of task, you also see a wide variety of trials – in the last year alone I have been involved in dozens of trials across five therapeutic areas.